Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: A randomized controlled trial.

BACKGROUND: The value of intravenous oxycodone compared to morphine remains controversial. The purpose of this trial was to compare opioid-related adverse events (ORAES) of intravenous oxycodone and morphine after total hip arthroplasty. METHODS: Patients scheduled for total hip arthroplasty were enrolled in this study of post-operative pain treatment with intravenous oxycodone or intravenous morphine (ratio 1:1). After surgery, patients received similar drug regimens for titration in the post-operative care unit followed by intravenous patient-controlled analgesia (PCA). The primary outcome was the number of patients with ≥1 ORAEs within the first 24 hours defined as either nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, hallucinations. Secondary outcomes included pain scores and opioid consumption. RESULTS: The analysis included 238 patients with similar characteristics. There were 55 patients with at least one ORAEs in the oxycodone group vs 46 in the morphine group: 48% vs 40%, P = .19; relative risk = 1.22 (0.91:1.63). Intravenous oxycodone vs intravenous morphine requirements were respectively (median, IQR): 6 (0-11) vs 8 (0-12) mg (P = .06) for titration, 15 (8-26) vs 8 (5-16) mg (P = .001) for PCA, and 22 (12-37) mg vs 19 (11-28) mg for cumulated intravenous consumption (P = .048). During the first 24 hours, there was no difference in secondary outcomes (oxycodone vs morphine, respectively, in %): nausea (15 vs 13), vomiting (5 vs 5), urinary retention (20 vs 12) or pain scores. CONCLUSION: This study demonstrates that IV oxycodone did not significantly reduce ORAEs within the first 24 hours compared to similar ratio of IV morphine.

Multimodal oral analgesia strategy after ambulatory arthroscopic shoulder surgery: case series using adaptive therapeutic approaches by sequential analysis.

BACKGROUND: Pain control and quality of recovery (QoR) at home remains a challenge after ambulatory shoulder arthroscopy. This study aims to assess the QoR and pain relief using a sequential implementation strategy for rescue analgesic drugs. METHODS: After institutional review board approval, patients (>18 years, American Society of Anesthesiology [ASA] score 1-3 stable) scheduled for ambulatory surgery under general anesthesia with a single-shot interscalene nerve block were enrolled. After discharge, patients received standard information regarding the postoperative recovery and care consisting of a multimodal analgesic regime (acetaminophen and ketoprofen for 5 days). The first 48 postoperative hours allowed us to compare 3 different rescue drug regimes with a control group, in sequential order: tramadol (control group), tramadol + nefopam, immediate-release oxycodone (IR), and extended-release oxycodone (ER). The primary endpoint was the QoR 40 score at 48 hours after surgery. Secondary endpoints were pain relief and adverse events over a 7-day period. An intention-to-treat statistical analysis was performed with sequential analysis (as an interim analysis) every 20 patients. Results were recorded as medians and interquartiles (25-75). RESULTS: We analyzed 109 patients with similar characteristics among groups. The QoR 40 scores were similar for the tramadol group (168 [161-172]), the tramadol + nefopam group (161 [151-173], P = .09), and the IR group (164 [153-169], P = .17), but higher for the ER group (176 [167-181], P = .03). Concerning adverse events, drugs were interrupted more frequently in the tramadol + nefopam group (36 %). In the ER group, a higher quality of postoperative relief was attained in the domains of pain and sleep. CONCLUSION: The present study shows that a combination of IR and ER oxycodone over a short period of time (<48 hours) is associated with a better QoR at home after ambulatory shoulder surgery.

Sore throat following three adult supraglottic airway devices: A randomised controlled trial.

BACKGROUND: Sore throat is a common complaint after surgery. It affects patient satisfaction and can affect activity after discharge. The supraglottic airway device (SAD) offers an alternative to traditional tracheal intubation with potential benefit in preventing sore throat. OBJECTIVE: The aim of this study was to compare the incidence of sore throat following three different SADs, the laryngeal mask airway Unique (LMA-U) and the more recent LMA Supreme (LMA-S) and the I-gel. DESIGN: A randomised single-blind controlled three parallel-group trial. SETTING: University Hospital of Nîmes, Division of Anaesthesia Intensive Care Pain and Emergency, Nîmes, France, from April 2009 to September 2012. PATIENTS: A total of 546 patients scheduled to undergo elective surgery of less than 2 h under general anaesthesia were randomly allocated to receive the LMA-U, the LMA-S or the I-gel. INTERVENTIONS: Anaesthesia was induced with propofol and sufentanil and maintained with propofol or with sevoflurane in air-oxygen. After airway device insertion, intra-cuff pressure was adjusted to less than 60 mmHg (LMA-U, LMA-S) and pressure-controlled ventilation initiated. MAIN OUTCOMES: The primary study endpoint was to compare incidence of sore throat 24 h postoperatively (H+24) following placement of the LMA-U, LMA-S and the I-gel. Secondary endpoints were clinical performance (airway leak pressure, dynamic airway compliance, complications during maintenance), ease of use (device insertion time, success on first attempt, ease of insertion and removal) and other adverse events (neck or jaw pain, dysphonia, dysphagia, nausea and vomiting). RESULTS: The authors analysed 177, 174 and 173 patients who received LMA-U, the LMA-S and the I-gel, respectively. The primary endpoint was assessed in 436 patients. In total, 104 patients (23.9%) patients reported a H+24 sore throat, with no difference between groups (P = 0.34). H+24 dysphagia with liquids was higher (P = 0.0065) with the LMA-S (12.1%) compared with LMA-U (5.3%) and I-gel (2.9%). Airway leak pressure (cmH2O) was lower (P < 0.0001) with LMA-U [21 (18 to 27)] compared with I-gel [26 (20 to 30)] and LMA-S [25 (21 to 30)]. Device insertion time (sec) was shorter (P < 0.0167) with the I-gel [30 (20 to 40)] compared with the LMA-U [34 (23 to 48)] and LMA-S [32 (22 to 50)]. CONCLUSION: The incidence of postoperative sore throat was not significantly different between the three SADs studied.

Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study).

BACKGROUND: Reliable outcome measurement providing information both on early and late postoperative pain outcomes are still lacking. The purpose of this study was: 1) to characterise postoperative pain trajectories according to an innovative pragmatic concept: ideal pain trajectory (rapid and sustained pain relief) vs non-ideal pain trajectories (late, transient, or no pain relief); and 2) to assess the incidence of persistent post-surgical pain (PPSP) and the potential association between non-ideal pain trajectories and PPSP. METHODS: This prospective observational pilot cohort study was performed from March until June 2016. A total of 344 patients undergoing major general surgery were invited to complete a self-assessment of pain intensity using numerical rating scale (NRS; 0 = no pain to 10 = worst pain) from day 1 until day 7 after surgery, in order to establish their pain trajectory. Three months after surgery, patients were screened for PPSP. RESULTS: Rest pain score was analysed in 308 participants. Among them, 210 (68% - 95% CI: 63-73) had an "ideal" pain trajectory, while 98 (32% - 95% CI: 27-37) had "non-ideal" pain trajectories. Three months after surgery, 31% (95% CI: 26-37) reported PPSP. Multivariable analysis showed that "non-ideal" pain trajectories [OR 2.25; (95% CI: 1.26-4.01) P = 0.006] were significantly associated with PPSP. CONCLUSIONS: The present study proposes an innovative pragmatic concept of postoperative pain trajectories: ideal vs non-ideal pain trajectories, providing information both on acute postoperative pain resolution and early identification patients at risk for developing PPSP. TRIAL REGISTRATION: NCT02599233; November, 6, 2015, with clinicaltrials.gov.

A comparison of the pharmacodynamics and pharmacokinetics of bupivacaine, ropivacaine (with epinephrine) and their equal volume mixtures with lidocaine used for femoral and sciatic nerve blocks: a double-blind randomized study.

BACKGROUND: Mixtures of lidocaine with a long-acting local anesthetic are commonly used for peripheral nerve block. Few data are available regarding the safety, efficacy, or pharmacokinetics of mixtures of local anesthetics. In the current study, we compared the effects of bupivacaine 0.5% or ropivacaine 0.75% alone or in a mixed solution of equal volumes of bupivacaine 0.5% and lidocaine 2% or ropivacaine 0.75% and lidocaine 2% for surgery after femoral-sciatic peripheral nerve block. The primary end point was onset time. METHODS: In a double-blind, randomized study, 82 adults scheduled for lower limb surgery received a sciatic (20 mL) and femoral (20 mL) peripheral nerve block with 0.5% bupivacaine (200 mg), a mixture of 0.5% bupivacaine 20 mL (100 mg) with 2% lidocaine (400 mg), 0.75% ropivacaine (300 mg) or a mixture of 0.75% ropivacaine 20 mL (150 mg) with 2% lidocaine (400 mg). Each solution contained epinephrine 1:200,000. Times to perform blocks, onset times (end of injection to complete sensory and motor block), duration of sensory and motor block, and morphine consumption via IV patient-controlled analgesia were compared. Venous blood samples of 5 mL were collected for determination of drug concentration at 0, 5, 15, 30, 45, 60, and 90 min after placement of the block. RESULTS: Patient demographics and surgical times were similar for all four groups. Sciatic onset times (sensory and motor block) were reduced by combining lidocaine with the long-acting local anesthetic. The onset of bupivacaine-lidocaine was 16 +/- 9 min versus 28 +/- 12 min for bupivacaine alone. The onset of ropivacaine-lidocaine was 16 +/- 12 min versus 23 +/- 12 for ropivacaine alone. Sensory blocks were complete for all patients within 40 min for those receiving bupivacaine-lidocaine versus 60 min for those receiving bupivacaine alone and 30 min for those receiving ropivacaine-lidocaine versus 40 min for those receiving ropivacaine alone (P < 0.05). Duration of sensory and motor block was significantly shorter in mixture groups. There was no difference among groups for visual analog scale pain scores and morphine consumption during the 48 h postoperative period, except for bupivacaine alone (median: 9 mg) versus bupivacaine-lidocaine mixture (15 mg), P < 0.01. There was no difference in the incidence of adverse events among groups. Plasma concentrations of bupivacaine and ropivacaine were higher, and remained elevated longer, in patients who received only the long-acting local anesthetic compared to patients who received the mixture of long-acting local anesthetic with lidocaine (P < 0.01). CONCLUSION: Mixtures of long-acting local anesthetics with lidocaine induced faster onset blocks of decreased duration. Whether there is a safety benefit is unclear, as the benefit of a decreased concentration of long-acting local anesthetic may be offset by the presence of a significant plasma concentration of lidocaine.

The Simplified Predictive Intubation Difficulty Score: a new weighted score for difficult airway assessment.

BACKGROUND AND OBJECTIVE: Using the Intubation Difficulty Scale (IDS) more than 5 as a standardized definition of difficult intubation, we propose a new score to predict difficult intubation: the Simplified Predictive Intubation Difficulty Score (SPIDS). METHODS: We prospectively studied 1024 patients scheduled for elective surgery under general anaesthesia. Using bivariate and multivariable analysis, we established risk factors of difficult intubation. Then, we assigned point values to each of the adjusted risk factors, their sum composing the SPIDS. We assessed its predictive accuracy using sensitivity, specificity, positive (PPV) and negative predictive values (NPV), and the area under the receiver operating characteristic (ROC) curve (AUC), and compared it with the corresponding nonweighted score. The optimal predictive level of the SPIDS was determined using ROC curve analysis. RESULTS: We found five adjusted risk factors for IDS more than 5: pathological conditions associated with difficult intubation (malformation of the face, acromegaly, cervical rheumatism, tumours of the airway, and diabetes mellitus), mouth opening less than 3.5 cm, a ratio of patient's height to thyromental distance 25 at least, head and neck movement less than 80 degrees , and Mallampati 2 at least. Sensitivity, specificity, PPV and NPV of the SPIDS were 65, 76, 14 and 97%, respectively. AUC of the SPIDS and the nonweighted score (obtained previously using a stepwise logistic regression) were respectively 0.78 [95% confidence interval (CI) 0.72-0.84] and 0.69 (95% CI 0.64-0.73). The threshold for an optimal predictive level of the SPIDS was above 10 of 55. CONCLUSION: The SPIDS seems easy to perform, and by weighting risk factors of difficult intubation, it could help anaesthesiologists to plan a difficult airway management strategy. A value of SPIDS strictly above 10 could encourage the anaesthesiologists to plan for the beginning of the anaesthetic induction with 'alternative' airway devices ready in the operating theatre.

Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial.

BACKGROUND: After general anaesthesia (GA) in adults, the optimal tracheal extubation technique (positive pressure or suctioning) remains debated. The primary endpoint of this study was to assess the effects of these techniques on onset time of desaturation (SpO2<92%). METHODS: Sixty-nine patients with a body mass index<30 scheduled for elective orthopaedic surgery were allocated to positive pressure (PP) or suctioning (SUC) group. GA was standardised with propofol and remifentanil via target-controlled infusion. A morphine bolus of 0.15mg/kg was administered 20-30mins before the end of surgery. The effect of extubation technique on onset time of desaturation (T92) was assessed during the first 10mins after extubation during the spontaneous air breathing. Secondary endpoints included: frequency of desaturation, respiratory complications, need to use oxygen therapy and SpO2 at the end of the first hour while breathing in air (ClinicalTrials.gov identifier: NCT01323049). RESULTS: Baseline patient characteristics and intraoperative management data for the 68 patients included had no relevant clinical difference between groups. T92 (sec) after tracheal extubation was 214 (168) vs. 248 (148) in the PP and SUC groups, respectively (P=0.44). In the PP and SUC groups, 50 and 43% reached a SpO2<92% within the first 10mins after extubation respectively (P=0.73). There were no statistically significant differences between groups for any secondary endpoints. CONCLUSIONS: Positive pressure extubation as compared with suctioning extubation did not seem to delay onset time of desaturation after GA in standard weight adult patients.

Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study.

BACKGROUND: Because nefopam's morphine-sparing is debated when combined with paracetamol, this study aimed to assess pain relief by IV nefopam in combination with paracetamol after major abdominal surgery. METHODS: This was a prospective, double-blinded randomized controlled study including patients (ASA I-III, >18 years) scheduled for elective colectomy surgery by laparotomy. Patients were randomized into the nefopam group (N.=37, continuous IV 120 mg nefopam) or control group (N.=32, placebo, same infusion) for 48 hours after surgery (both groups: IV paracetamol 1 g/6 h + IV PCA morphine rescue). The primary endpoint was the total morphine consumption from the potential titration in the postoperative care unit to 48 hours (20% reduction in nefopam group). The secondary endpoints were adverse events and clinical outcomes. RESULTS: Both groups were similar for demographic characteristic, surgery, and anesthesia (including IV sufentanil 20 [20-25] µg for nefopam vs. 22.5 [20-25] µg for the control, P=0.6). Time in PACU and hospital stay were not statistically different. The number of patients requiring titration in PACU and the amount of IV morphine titration were similar. As the main endpoint, morphine consumption over the study period was similar between nefopam and the control group (respectively, 53±37 and 54±34 mg, P=0.86). No difference was observed for pain relief satisfaction between groups or total adverse events like PONV, ileus, desaturation, or confusion (nefopam 14±38 vs. control group 11±34, P=0.77). CONCLUSIONS: This prospective randomized study suggested that nefopam in combination with paracetamol has no benefit after open abdominal surgery.

Comparison of 3 intensities of stimulation threshold for brachial plexus blocks at the midhumeral level: a prospective, double-blind, randomized study.

BACKGROUND: We conducted this prospective randomized study to compare the success rate and the onset time between 3 intensities of stimulation threshold (<0.5, 0.5-0.64, and 0.65-0.8 mA) when using a peripheral nerve stimulation at the midhumeral level. METHODS: Sixty-nine adult patients undergoing elective hand surgery were studied. Blocks were performed using conventional nerve stimulation technique. Needle advance began at 2 mA (1 Hz, 0.1 millisecond). When motor response (MR) occurred at less than 0.5 mA, needle position was fixed for "group <0.5 mA." For "group 0.5-0.64 mA," the needle was withdrawn until MR occurred at greater than 0.5 mA and disappeared at less than 0.5 mA. For "group >0.65 mA," the needle was withdrawn until MR occurred at greater than 0.65 mA and disappeared at less than 0.65 mA. For each group, patients received 8 mL of ropivacaine 7.5 mg/mL on the 4 nerves (radial, median, ulnar, and musculocutaneous). Primary end point was the number of failed radial nerve sensory blocks at 30 mins. RESULTS: The time to perform the block was not different between the 3 groups (17 mins [SD, 7 mins] vs 13 mins [SD, 8 mins] and 13 mins [SD, 4 mins], respectively). The time required to obtain a complete sensory block was shorter for the 4 nerves in group <0.5 mA, with a statistical significance for radial and musculocutaneous nerves in group <0.5 mA versus group 0.5-0.64 mA and group >0.65 mA. Patients in group <0.5 mA had a greater success rate for complete sensory radial nerve compared with those of group 0.5-0.64 mA and group >0.65 mA at any interval times between 5 and 30 mins (P = 0.0001). Supplemental local anesthesia was provided for the 3 groups more frequently for the median nerve, with no difference between groups. Group >0.65 mA required 5 general anesthesias (20%) as compared with 1 (4%) in group <0.5 mA (P < 0.05). No adverse event (dysesthesia) occurred after 48 hrs and 45 days. CONCLUSION: We conclude that intensity of stimulation influenced onset time and success rate.

Comparison of the parasacral approach and the posterior approach, with single- and double-injection techniques, to block the sciatic nerve.

BACKGROUND: The purpose of this study was to compare parasacral and Winnie's single- or double-injection approaches for sciatic nerve block. METHODS: One hundred fifty adults scheduled to undergo lower limb surgery were randomized to receive on the sciatic nerve 20 ml ropivacaine, 0.75%: single bolus for parasacral and Winnie's single injection. For Winnie's double injection, the peroneal and tibial nerves received separately 10 ml plus 10 ml. Blocks were performed with the use of nerve stimulator (intensity < 0.5 mA, 1 Hz). For the parasacral method, a line was drawn between the posterior superior iliac spine and the ischial tuberosity; needle entry was at 6 cm inferior to the posterior superior iliac spine. RESULTS: The groups were similar. Time to perform the block was 2 (1-5) min for the parasacral method, with no difference from Winnie's single injection (3 [1-10] min), but was shorter with double injection (5.5 [2-15] min) (P = 0.0001). Onset of sensory block was similar in the parasacral (25 [7.5-50] min) and Winnie single-injection groups (25 [5-50] min) but significantly longer in the double-injection group (15 [5-50] min). Success rates for complete block were similar in the parasacral (66%) and Winnie's double-injection groups (68%) after 30 min but higher in the Winnie's single-injection group for tibial sensory and motor block (48%) (P < 0.017). CONCLUSION: Time to perform a parasacral block was short, and the parasacral approach had a high success rate and a short onset time. Therefore, this block might be a useful alternative to Winnie's modification for sciatic nerve block.

Ophthalmic regional anesthesia: medial canthus episcleral (sub-tenon) single injection block.

BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of episcleral single-injection anesthesia in a large number of patients. METHODS: Over a period of 5 yr, in four institutions, anesthesiologists involved in this prospective study completed a standardized form to evaluate single-injection medial canthus high-volume episcleral anesthesia. The success rate of the block was rated according to an akinesia score. The study parameters included demographic data, surgical procedure, and anesthetic management. All patients were followed up at least until postoperative day 1, and all complications, pain, and discomfort were noted. Statistical analysis was done to assess the risk factors for complications. RESULTS: A total of 2,031 patients were included in the study. The most frequent surgical procedures performed were phacoemulsification and posterior chamber artificial lens implantation (91.0%). A total of 66 complications (3.3%) occurred in 60 patients. One patient had a retrobulbar hemorrhage, and 59 had one or two more minor incidents or pain/discomfort with the procedure. The complications consisted of subconjunctival hematoma (1.3%), ocular hypertonia (0.4%), and chemosis (0.30%). Statistical analysis revealed that inexperience in the technique represented a risk factor for complications. CONCLUSIONS: This is the first survey of a large experience in episcleral single-injection anesthesia, a form of anesthesia that does not preclude sharp-needle complications and does require training. Only one complication occurred among 2,031 patients; however, a larger number of patients is needed to definitively evaluate the safety of episcleral single-injection anesthesia.